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WASHINGTON, D.C. – Today, Congressman Frank Pallone, Jr. (D-NJ) and Senator Kirsten Gillibrand (D-NY) sent a letter to Margaret A. Hamburg, Commissioner of the Food and Drug Administration (FDA), urging the agency to evaluate the safety of oral care products, such as toothpastes and gum, that contain polyethylene microbeads. Accounts from both consumers and dental professionals suggest that these small bits of plastic, which are not biodegradable, may get lodged in crevices between the teeth and gums, trapping bacteria and potentially threatening oral health. Pallone and Gillibrand wrote that closer monitoring by the FDA is needed in order to confirm that products containing microbeads pose no risk to public health.

“In addition to polluting our environment, these tiny plastic particles may also be jeopardizing our health,” said Congressman Pallone. “And what is especially concerning is that so many people buy these products, unaware of the potential risks. When American families are using these toothpastes and chewing this gum, we ought to know definitively whether or not these products are dangerous. FDA should conduct a proper investigation in order to determine if using microbeads in products that consumers ingest is safe.”

“Plastic microbeads are seriously harming our environment, and the only way to begin reversing the damage is to get them out of our products, including our toothpaste,” said Senator Gillibrand. “There are many natural alternatives that don’t cause ecological problems the way plastic microbeads do. Banning these pollutants at the federal level is the smartest solution going forward, and I look forward to getting this bill passed.”

In the letter, the lawmakers took issue with FDA’s regulation of these over-the-counter products. While polyethylene has been approved by the agency to be used in packaging materials, it has never specifically been approved to be ingested by consumers. Since FDA currently defers regulation of the safety of products containing plastic microbeads to the manufacturers themselves, many companies can claim that microbeads are used as a cosmetic additive rather than an active ingredient. However, since small amounts of oral care products, like toothpaste, are often swallowed by users, Pallone and Gillibrand called on FDA to ensure the safety of these products that contain polyethylene microbeads.

In light of growing concerns from consumers and dental professionals, some companies, including Procter and Gamble, the manufacturer of Crest toothpaste, have voluntarily started the process of phasing out the use of microbeads in their oral care products.

Earlier this year, Pallone and Gillibrand introduced legislation, the Microbead-Free Waters Act of 2014, to address the harmful environmental impacts of microbeads in personal care products. Often used as exfoliants in personal care products like face wash and soap, microbeads can slip through water treatment systems after they are washed down the drain. As a result, they often end up in local streams, rivers and larger bodies of water.

Scientists have found evidence of microbeads in numerous bodies of water in the United States, including increasingly in the Great Lakes, the world’s largest source of freshwater. In addition to contributing to the buildup of plastic pollution in waterways, microbeads can often be mistaken by fish and other organisms as food. If consumed, the chemicals found in synthetic plastic microbeads can then be passed on to other wildlife and humans.

The bill introduced by Pallone and Gillibrand would ban the sale or distribution of cosmetic products containing plastic microbeads effective January 1, 2018. Recently, the New Jersey Legislature passed a bill banning the manufacture of products containing plastic microbeads by the end of 2017, and the State of Illinois has already passed a similar ban into law. Natural alternatives to plastic microbeads already exist in the market.

Please find the complete text of the letter below:

November 14, 2014

The Honorable Margaret A. Hamburg

Commissioner

Food and Drug Administration

Department of Health and Human Services

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner Hamburg:

We are writing to address the Food and Drug Administration's (FDA) treatment of polyethylene microbeads in oral care products. Though it appears no clinical investigation of the issue has been conducted to substantiate this concern, a growing body of anecdotal evidence from consumers and dental professionals suggests that closer monitoring is needed to confirm that in fact, products containing microbeads pose no risk to human health.

Together we have worked to address the environmental impacts of microbeads in personal care products, leading to the introduction of the Microbead-Free Waters Act. Synthetic plastic microbeads are difficult to trap or catch in the sewage system, which unfortunately leads to these tiny plastic particles ending up in local streams, rivers and larger bodies of water. Scientists have found evidence of microbeads in numerous bodies of water in the U.S., including the Great Lakes, the world’s largest source of freshwater. In addition to contributing to the buildup of plastic pollution in waterways, microbeads can often be mistaken by fish and other organisms as food. If consumed, the chemicals found in synthetic plastic microbeads can then be passed on to other wildlife and humans.

However, accounts from consumers and dental professionals suggest that microbeads pose a potential threat to oral health as well. In many users of associated toothpastes, these microbeads may get trapped in the gingival sulcus, trapping bacteria as well, leading to gingivitis and adversely impacting oral health. Because microbeads are not biodegradable, the buildup of bacteria over time can ultimately lead to advanced periodontal disease, affecting the surrounding soft tissue and bone, which imposes even greater impacts on physical health.

Our concern arises largely from FDA's regulatory approach in these over the counter products. Polyethylene has been approved by the FDA to come into contact with food products as a packaging material, but has never been approved specifically for use in this manner. Toothpaste is often ingested in small amounts by users, which gives reason for concern, since FDA has never evaluated the safety of the product in this application. Additionally, manufacturers have continued to evade greater scrutiny from the agency by claiming that microbeads are intended as a cosmetic additive, and not an active ingredient, contrary to messages in advertising. Under this questionable classification, FDA defers regulation of the safety of products containing microbeads to manufacturers themselves.

In light of the growing concern over the use of microbeads from both environmental and oral health standpoints, and the widespread use of microbeads in oral health products from gum to toothpaste, we are glad that Proctor and Gamble has voluntarily chosen to phase out the use of microbeads in all oral care products by March of 2016.

However, relying entirely on self-regulation may jeopardize public health. Normal use of these products, as recommended by the products' manufacturers and by dental professionals, may significantly impact oral health. Given the agency's mission to safeguard consumers and in light of growing concerns from consumers and dental professionals, we ask that FDA undertake greater measures to ensure the safety of oral care products that utilize polyethylene microbeads.